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Reveal

FDA UDI

Class II (US FDA UDI)

by Oticon A/S

Identity

Trade Name
Reveal FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-the-ear FDA UDI
Device Name
G50, MINIRITE T 312 2.4G C090 REVEAL FDA UDI
Model / Reference
177293 FDA UDI
Description
G50, MINIRITE T 312 2.4G C090 REVEAL FDA UDI

Identifiers

Primary DI / UDI-DI
05711584072349 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-the-ear

Reveal by Oticon A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, receiver-in-the-ear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oticon A/S

Sources (1)

  • FDA UDI 0d7bf8e0-541f-41b4-8f28-197cd3580339 34 fields · synced Jun 8, 2026